invasive pancreatic ductal adenocarcinoma invasive pancreatic ductal adenocarcinoma, potentially resectable pancreatic cancer
Conditions
Interventions
Test group: neoadjuvant gemcitabine plus S-1 based chemoradiotherapy
Patients receive orally S-1twice daily at a dose of 60mg/m2/day on days 1 through 21 of a 28-day cycle and an infusion of gemcitabine at a dose of 600 mg/m2 on days 8, 22, 36, and 50. Patients were tr
Patients receive gemciabine at a dose of 1000mg/m2 on days 1 and 8 plus S-1 orally twice daily at a dose according to the BSA (less than 1.25 m2, 80mg/day
1.25 or more to less tan 1.5, 100mg/day
1.5 or more, 120mg/day) on days 1 through 14 of a 21 day cycle.
neoadjuvant gemcitabine plus S-1 based chemoradiotherapy
Sponsors
Mizuno Shugo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. age at the time of registry is 20 or more, 79 or less 2. newly diagnosed invasive pancreatic ductal adenocarcinoma (PDAC) confirmed by imaging study and histological or cytological studies. 3. no distant metastasis 4. potentially resectable PDAC according to the resectability of Japan Pancreas Society 7th classification based on contrast enhanced multidetector CT imaging. 5. toleable curative resection 6. no previous anti-tumor treatment 7. Eastern Cooperative Oncology Group performance status, 0, 1 8. adequate hematological, hepatic, renal, and cardiopulmonary functions 9. adequate ability of oral intake 10. written informed consent before enrolling the study
Exclusion criteria
Exclusion criteria: Patients who: 1) is allergic to the chemotherapeutic agents. 2) has pulmonary fibrosis or intestinal pneumonia. 3) has active infectious disease. 4) has simulatenous active cancer. 5) is plegnant or has possibility to become pregnant during the study. 6) is considered ineligible for enrolling the study by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| histological response (Grade 1, 2, 3, 4) in the resected specimens according to the Japan Pancreas Society 7th classification | — |
Secondary
| Measure | Time frame |
|---|---|
| radiographic response according to revised RECIST guideline, rate of curative-intent resection, degree of residual tumor, 2-year and 5-year overall survival rate, rate of postiopeative complication, rate of recurrence after surgery, mode of recurrence | — |
Contacts
Public ContactYasuhiro Murata
Department of Hepatobiliary Pancreatic and Transplant Surgery, Mie University Hospital
Outcome results
None listed